VENETA-100 mg (Venetoclax INN )

Description

Venetoclax INN

Composition: Veneta-100: Each film coated tablet contains Venetoclax INN 100mg.

Indications: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Venetoclax is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Acute Myeloid Leukemia: Venetoclax is indicated in combination with Azacitidine, or Decitabine, or low-dose Cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Dosage & administration: In Combination with Obinutuzumab: Start Obinutuzumab administration at 100 mg on Cycle 1 Day 1, followed by 900 mg on Cycle 1 Day 2. Administer 1000 mg on Days 8 and 15 of Cycle 1 and on Day 1 of each subsequent 28-day cycle for a total of 6 cycles. Refer to the Obinutuzumab prescribing information for additional dosing information. On Cycle 1 Day 22, start Venetoclax according to the 5-week ramp-up dosing schedule (see Table 1). After completing the ramp-up phase on Cycle 2 Day 28, continue Venetoclax at a dose of 400 mg orally once daily from Cycle 3 Day 1 until the last day of Cycle 12. In Combination with Rituximab: Start Rituximab administration after the patient has completed the 5-week ramp-up dosing schedule for Venetoclax (see Table 1) and has received Venetoclax at the recommended dosage of 400 mg orally once daily for 7 days. Administer rituximab on Day 1 of each 28-day cycle for 6 cycles, at a dose of 375 mg/m² intravenously for Cycle 1 and 500 mg/m² intravenously for Cycles 2-6. Continue Venetoclax 400 mg orally once daily for 24 months from Cycle 1 Day 1 of Rituximab. Monotherapy: The recommended dosage of Venetoclax is 400 mg once daily after completion of the 5-week ramp-up dosing schedule. Continue Venetoclax until disease progression or unacceptable toxicity. Or, as directed by the registered physicians.

Pregnancy & lactation: Venetoclax may cause embryo-fetal harm when administered to a pregnant woman. There are no available data on Venetoclax use in pregnant women to inform a drug-associated risk. There are no data on the presence of Venetoclax in human milk or the effects on the breastfed child or milk production.